This page lists enhancements to CDRH's Electronic Medical Device Reporting (eMDR) system. The FDA eSubmitter client is updated concurrently with the eMDR system, but industry with system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG), should use the information on this page to plan system updates to align with these eMDR system enhancements as soon as possible.
The FDA recognizes the importance of providing early notice and predictability about potential eMDR system changes, especially for manufacturers submitting HL7 ICSR XML reports via AS2. Therefore, the FDA is adopting a yearly schedule for announcing and implementing enhancements to the eMDR System.
Through this schedule, the FDA expects to take the next steps for every cycle of new enhancements:
- Announce upcoming enhancements every June,
- Release the Implementation package in August,
- Deploy enhancements to pre-production (ESG Test) also in August, and
- Deploy enhancements to production in March of the following year.
While FDA expects to follow this schedule for future enhancements, it is possible that emergency fixes may need to be implemented outside the schedule. Additionally, if major system changes are necessary in the future, additional time will be provided between release of the implementation package and production deployment.
2022 Upcoming Enhancements
The 2022 enhancements include:
- Not accepting reports that provide a Patient Age but do not provide the patient age unit in A2.
- Not accepting reports that do not identify the Product Code in D2b.
- Not accepting reports where the “implant date” (D6a) is after the “explant date” (D6b), if both dates are provided.
- Not accepting reports that do not provide a contact email address in G1 (for manufacturers) or F3 (for distributors and importers).
- Not accepting reports that do not include Adverse Event Problem codes in H6 (for manufacturers) or F10 (for distributors and importers); specifically, Medical Device Problem Code and Health Effect- Clinical Code.
- Updating adverse event coding sets to align with International Medical Device Regulators Forum (IMDRF) 2022 published updates.
More information on the precise changes to the eMDR system, will be released in August in the eMDR implementation package, a packet of files to assist in implementing software for generating the Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) XML for an eMDR submission.
Shortly after the implementation package is released in August, the enhancements will be deployed to the pre-production (ESG Test) environment. Production deployment will be in March 2023.
We will provide regular communications on this page at each of these points in the process. This information will also be emailed to CDRH’s manufacturer email list.
Please contact the eMDR helpdesk at eMDR@fda.hhs.gov for any questions or concerns about specifications and enhancements.
Historical Changes to eMDR
|IMDRF 2021 maintenance updates||The Adverse Event codes accepted in sections F10 and H6 of the 3500A form were updated to harmonize with maintenance updates from IMDRF. To see a summary of the changes and download the new hierarchy files, go to Coding Resources. Industry with system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG), should update their systems as soon as possible to match.||Test deployment to eMDR on February 21, 2021. Production deployment to eMDR and eSubmitter on March 5, 2021.|
|Exemption Number field added||A new element indicating the Exemption Number associated with the MDR (if any) was added to eMDR and eSubmitter, so submitters need not report this information in Section H10 (Additional Manufacturer Narrative) with precise text formatting. Submitters should cease reporting exemption numbers in H10, and instead use this new Exemption Number field.||Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020.|
|Overview of updates to the FDA Form 3500A with expiration date 2021-Nov-30||
The eMDR system was updated to include fields from the newest version of the FDA Form 3500A. The additions included new options in A3 Patient Gender, new fields for C6 Generic and Biosimilar, a new field for D8 Device Serviced By a Third Party, new options for E3 Reporter Occupation, a new field for G4 PreANDA, a new field for G5 Combination Product, new fields in H1 for Summary Report, for example, Voluntary Malfunction Summary Reports (VMSR) and Number of Events (see NOE update below), and new fields for H6 Health Effect Impact Code and Medical Device Component Code (see International Medical Device Regulators Forum (IMDRF) Annex E, F, G codes updates below). AS2 submitters should refer to the eMDR Implementation Package for a complete list of changes.
|Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020.|
|IMDRF Annex E, F, G code updates||The Adverse Event codes accepted in F10 and H6 were updated to complete harmonization with the IMDRF Adverse Event Reporting Terminologies. This update added new code sets for Annexes E (Patient Problem Code, now called Health Effect Clinical Code), F (Health Effect Impact Code), and G (Medical Device Component Code), as well as maintenance updates (including new codes) for the Medical Device Problem Code set (Annex A). A new field for component codes was added to the FDA Form 3500A with expiration date 2021-Nov-30 and they will no longer be accepted in other code fields. All FDA code sets were renamed to their IMDRF names, and IMDRF codes are now accepted by eMDR in addition to the corresponding FDA and National Cancer Institute Thesaurus (NCIt) codes. For more information on the new and retired codes, please view the hierarchy and disposition files posted at MDR Adverse Event Codes. eMDR began rejecting MDRs containing Patient Problem codes and Device Component codes retired during this update on March 5, 2021.||Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020.|
|Summary Report and NOE fields added||As part of the update to the FDA Form 3500A with expiration date 2021-Nov-30, new elements for Summary Report and NOE (Number of Events) for use in summary MDR reporting were added to H1, so that submitters will not need to report this information in B5 (Event Narrative) with precise text formatting. These elements should be used for all summary MDR reporting, for example, VMSR. Submitters should cease reporting NOE elements in B5.|
|Country code formats clarification||The eMDR implementation package was updated to clarify the formatting of country codes in the address fields. Two-letter codes are interpreted as FIPS 10-4 and three-letter codes are interpreted as GENC. AS2 submitters should not send ISO 3166-1 two-letter and three-letter country codes to eMDR. Refer to the eMDR Implementation Package for a complete list of accepted country codes.||Effective May 28, 2020.|
|Supplement Numbering Requirements Enforcement||The eMDR system was updated to enforce requirements related to supplement report numbering. In the past, supplements that were sent with incorrect follow-up numbers (for example, a supplement #2 for a report without supplement #1) would be accepted and placed into "supplement hold" while the eMDR system waited for the missing supplement(s) to arrive. Now, a supplement with an incorrect follow-up number will be rejected, and Ack3 will contain a message explaining which follow-up numbers are missing for the report in question. For more information on the new Ack3 error messages, please view the sample acknowledgement files in the eMDR Implementation Package.||Production deployment to eMDR on December 27, 2018.|
|FDA Adverse Event codes update||The list of FDA Adverse Event codes accepted in F10 and H6 was updated to harmonize with the IMDRF Adverse Event Reporting Terminologies. This update affected the Device Problem Codes and Manufacturer Evaluation Codes, which correspond to IMDRF Annexes A through D. Future updates will harmonize all remaining FDA adverse event codes with IMDRF as more annexes are published. IMDRF codes are not accepted by eMDR, but the new hierarchies posted on FDA.gov include a one-to-one mapping of IMDRF codes to FDA codes. AS2 submitters who use FDA codes retired during this update will have their report rejected by eMDR. For more information on the new and retired codes, please view the hierarchy and disposition files posted at MDR Adverse Event Codes.||Test deployment to eMDR on March 6, 2018. Production deployment to eMDR and eSubmitter on July 5, 2018.|
|Environment and Submission Type elements added to Ack3||A new element indicating the submission environment (production or test) was added to both the HTML and XML Ack3. This element allows submitters to detect when they have accidentally submitted to the wrong environment. Also, a new element indicating the CDRH submission type (FDA Form 3500A for eMDR) was added to both versions of Ack3.||Test deployment to eMDR on April 7, 2017. Production deployment to eMDR on October 2, 2017.|
|HL7 ICSR R2 XML format update||The eMDR system was updated to accept HL7 ICSR R2 format XML, and eSubmitter was updated to generate R2 XML for all submissions. Although the R2 schema allows for multiple devices and multiple patients in a single report, eMDR will continue to accept only one device and one patient per report. AS2 submitters can indicate whether their XML is in R1 or R2 format using a new schema element (submissions without this element will continue to be processed as R1). After a one-year grace period, eMDR ceased accepting R1 format submissions on July 5, 2018.||Production deployment to eMDR and eSubmitter on June 29, 2017.|
|Combination product fields added||The new eMDR ICSR R2 XML includes elements from sections C and G of the FDA Form 3500A that contain drug information. This allows submitters to include information of up to 20 drugs within a device-led combination product adverse event report in eMDR.||Production deployment to eMDR and eSubmitter on June 29, 2017.|
|FDA Form 3500A version 9/30/2018 updates||The eMDR system was updated to include fields from the newest version of the FDA Form 3500A. The major addition was section A5 (Ethnicity/Race). This field is not mandatory for eMDR submissions, but FDA requested that AS2 submitters add this field to their systems by July 5, 2018.||Production deployment to eMDR and eSubmitter on June 29, 2017.|
|D4 UDI guidance update||Submitters were previously instructed to enter the full human-readable UDI in the D4 UDI field. This guidance has been updated to request that manufacturers include only the DI portion of the UDI in this field. User Facility reporters that are not aware of the suspect medical device's DI should continue to enter the full human-readable UDI printed on the device.||Effective June 1, 2017.|
|Mandatory B5 and H1||Manufacturer initial reports must include a value for B5 and H1. Reports that contain only whitespace for B5 will be rejected. Reports that do not indicate Death, Serious Injury, or Malfunction in H1 will be rejected.||Production deployment to eMDR and eSubmitter on February 2, 2017.|